(107 days)
The ClearPoint Bone Screw Fiducials are intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.
The ClearPoint Bone Screw Fiducials are titanium bone screw fiducials that provide fixed reference points during neurosurgical procedures.
The ClearPoint Bone Screw Fiducial Kit is provided sterile and is composed of the following:
- 5x - ClearPoint Bone Screw Fiducials
- 1x Bone Screw Fiducial holder
- 1x Screwdriver
The Bone Screw Fiducial is made of titanium and comprised of a threaded portion that is screwed into a patient's skull and a non-threaded, exposed length that protrudes from the patient's head. The head contains a feature for compatibility with a T8 Torx screwdriver and small divot positioned at the center of the spherical head which is used to center the pointer tip of a navigation tool.
The Bone Screw Holder is intended to assist in holding the Bone Screw Fiducials securely to the screwdriver during anchoring. This is accomplished by allowing the screwdriver to mate with the Bone Screw Fiducial without the Bone Screw Fiducial separating from the assembly therefore allowing it to be anchored to the skull.
The provided document is a 510(k) premarket notification for the ClearPoint Bone Screw Fiducials. It does not contain information related to software or AI/ML. The document describes a medical device, specifically bone screw fiducials, and compares them to a predicate device. The testing described is "bench testing" focusing on physical, performance, and safety requirements, and simulated workflow testing.
Therefore, for aspects related to AI/ML or a multi-reader multi-case (MRMC) study, the answer will be that this document does not contain that information.
Here's an analysis based only on the provided text, addressing the points where information is available:
1. A table of acceptance criteria and the reported device performance
The document states: "The results from all testing demonstrated that the ClearPoint Bone Screw Fiducials comply with all design and performance specifications."
It also mentions: "ClearPoint Bone Screw Fiducials have been demonstrated to meet all test specifications and has been shown to be as safe, as effective, and to perform as well as the predicate device."
However, the specific "acceptance criteria" and "reported device performance" metrics (e.g., specific thresholds for physical properties, accuracy in imaging, etc.) are not detailed within this document. The document summarizes that the device met these criteria but does not provide them in a table format.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "bench testing" and "simulated workflow testing." It does not specify sample sizes for these tests or discuss data provenance (country of origin, retrospective/prospective) in the context of clinical data or patient-derived data, as the device is physical hardware.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This N/A. Ground truth, in the context of AI/ML, refers to expert-labeled data. The testing described is bench testing of a physical device. There is no mention of experts establishing a "ground truth" for imagery or diagnostic performance here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This N/A. No adjudication method is described, as the testing is for physical device performance, not interpretation of data by multiple readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was conducted or mentioned in this document. This document is for a physical medical device (bone screw fiducials), not a software or AI/ML product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or mentioned. This document is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This N/A. For a physical device, "ground truth" typically refers to engineering specifications met through measurements and physical verification. The document states "Design Verification testing was performed relative to these specifications." These specifications serve as the "ground truth" for the device's physical and performance characteristics. There is no biological or diagnostic ground truth described in this submission.
8. The sample size for the training set
This N/A. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
This N/A. There is no training set mentioned, as this is not an AI/ML device.
Summary regarding AI/ML aspects:
The provided document describes a 510(k) premarket notification for a physical medical device (ClearPoint Bone Screw Fiducials). It relies on bench testing to demonstrate performance and substantial equivalence to a predicate device. The information requested regarding AI/ML-specific testing, such as MRMC studies, training/test set sizes, data provenance, expert ground truth establishment, and algorithm-only performance, is not relevant to this submission and therefore not present in the provided text.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).